MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 15MM - IDE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FDC45015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Pain (1994); Stenosis (2263); Numbness (2415)

Event Date 11/03/2021

Event Type  Injury  

Event Description

It was reported in a clinical trial that the patient was treated for a right internal carotid artery-clinoid (c5 segment) aneurysm with the subject flow diverter.The procedure was successful with the subject flow diverter completely covering the aneurysm neck and no reported complications.64 days post procedure, the patient presented to the emergency room after a ground level fall with left knee pain and upper extremity numbness.Imaging done showed more than 50% stenosis of the right internal carotid artery (ica).The patient was treated with pain management and physiotherapy.In the physician's opinion, the stenosis was related to patient's history of neck radiation.This event resolved 3 days later.144 days post procedure, the patient had a stroke that presented with right upper arm weakness/numbness which required a 2 day hospitalization.Imaging done showed 72% stenosis of the proximal right ica and a small cortical infarct.Treatment given during this time was unknown as patient was out of town but event resolved 6 days later.According to the site, there is a probability of the stroke being related to the underlying condition or disease.No ther information is available.

Manufacturer Narrative

Device is implanted in patient.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported in a clinical trial that the patient had left upper extremity numbness and more than 50% stenosis of the right internal carotid artery found on imaging 64 days post procedure with the subject flow diverter.144 days post procedure, the patient also had a stroke that presented with right upper arm weakness/numbness which required hospitalization.Additional information provided by the customer indicated that the device was implanted successfully without any device deficiencies noted during the procedure and the pi feels the subject's stenosis is related to his history of radiation therapy to his neck.The patient fall was not related to the vessel stenosis.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the as reported 'patient parent vessel stenosis', 'patient neurological deficit' and 'patient stroke' in this complaint.

Event Description

It was reported in a clinical trial that the patient was treated for a right internal carotid artery-clinoid (c5 segment) aneurysm with the subject flow diverter.The procedure was successful with the subject flow diverter completely covering the aneurysm neck and no reported complications.64 days post procedure, the patient presented to the emergency room after a ground level fall with left knee pain and upper extremity numbness.Imaging done showed more than 50% stenosis of the right internal carotid artery (ica).The patient was treated with pain management and physiotherapy.In the physician's opinion, the stenosis was related to patient's history of neck radiation.This event resolved 3 days later.144 days post procedure, the patient had a stroke that presented with right upper arm weakness/numbness which required a 2 day hospitalization.Imaging done showed 72% stenosis of the proximal right ica and a small cortical infarct.Treatment given during this time was unknown as patient was out of town but event resolved 6 days later.According to the site, there is a probability of the stroke being related to the underlying condition or disease.No ther information is available.

Event Description

It was reported in a clinical trial that the patient was treated for a right internal carotid artery-clinoid (c5 segment) aneurysm with the subject flow diverter.The procedure was successful with the subject flow diverter completely covering the aneurysm neck and no reported complications.64 days post procedure, the patient presented to the emergency room after a ground level fall with left knee pain and upper extremity numbness.Imaging done showed more than 50% stenosis of the right internal carotid artery (ica).The patient was treated with pain management and physiotherapy.In the physician's opinion, the stenosis was related to patient's history of neck radiation.This event resolved 3 days later.144 days post procedure, the patient had a stroke that presented with right upper arm weakness/numbness which required a 2 day hospitalization.Imaging done showed 72% stenosis of the proximal right ica and a small cortical infarct.Treatment given during this time was unknown as patient was out of town but event resolved 6 days later.According to the site, there is a probability of the stroke being related to the underlying condition or disease.No ther information is available.According to the additional information received on 21-jun-2022, it was reported that stroke was assessed by the cec member to have possible relationship to the subject flow diverter and the ground level fall with left knee pain was assessed by the cec member to have no relationship to subject flow diverter.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported in a clinical trial that the patient had a "ground level fall with left knee pain' and more than 50% stenosis of the right internal carotid artery, found on imaging 64 days post procedure with the subject flow diverter.144 days post procedure, the patient also had a "stroke" that presented with right upper arm weakness/numbness which required hospitalization.According to the additional information received on 21-jul-2022, it was reported that ae "stroke" was assessed by the cec member to have possible relationship to the subject flow diverter and the ae "ground level fall with left knee pain and left upper extremity numbness" was assessed by the cec member to have no relationship to subject flow diverter or other stryker devices.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to 'patient parent vessel stenosis' and 'patient stroke' in this complaint.

• Brand Name: SURPASS EVOLVE 4.5MM X 15MM - IDE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13831681
• MDR Text Key: 287896078
• Report Number: 3008881809-2022-00125
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2021
• Device Catalogue Number: FDC45015
• Device Lot Number: 22539001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 05/10/2022; 07/11/2022
• Supplement Dates FDA Received: 06/07/2022; 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 71 YR
• Patient Sex: Male